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The Evolution of the Medical Affairs Function

10 Dec 21

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In mid-2020, tranScrip ran a webinar on Medical Affairs in times of COVID-19, discussing how the pandemic is catalysing a change in the way that Pharma companies can best interact with health care professionals (HCPs).

This showed that the restrictions on meeting HCPs, whether in their offices or hospitals or at conferences, were driving new ways to meet scientific information needs and communicate value. Polling of attendees revealed that, while many Medical Affairs personnel found their HCP interactions to have been adversely affected by the pandemic, some were able to have more effective interactions through the development of highly engaging virtual solutions.

We are finally seeing a partial return to face-to-face personal meetings and conferences, but many HCPs have found the virtual alternatives to be very convenient, and it is likely that virtual/hybrid interactions are here to stay.

This experience has highlighted one of the many ways in which the role of Medical Affairs is continuing to evolve and becoming one of the most important in Pharma.

What is Medical Affairs and how is it changing?

Medical Affairs is the organisation within a pharmaceutical or medical device company that focuses on the communications between the company and the medical community, acting as a bridge between the company and a wide range of external stakeholders. These include prescribers and other medical professionals, thought leaders, healthcare providers, patients, professional and patient organisations, and payers.

The main roles of Medical Affairs are to communicate accurate and non-promotional scientific and clinical information through a variety of channels, and to manage relationships with key stakeholders.

Originally focused on information support and the management of routine regulatory reporting requirements, the scope has evolved to include proactive medical and scientific communications; communication of clinical and value stories that address unmet patient needs; development of medical brand strategy and scientific messaging; planning and implementation of post-launch and other non-registrational clinical trials and support of investigator-initiated studies; publication development and management; organisation of symposia, expert panels and advisory boards; creation of and support for external medical education; delivery of internal training; health economics and outcomes research (HEOR) activities; and management of medical science liaison (MSL) and field medical teams.

Medical Affairs also increasingly plays a leadership role in coordinating the needs of external stakeholders with and between other internal company departments such as commercial, market access, clinical development, drug safety, and regulatory.

Further evolution in Medical Affairs

As the pace of change in healthcare accelerates, Medical Affairs must continue to evolve to meet the needs of new stakeholders and the rising bar for value demonstration.

Key drivers include:

  • The more assertive role of patients and patient organisations in setting requirements for new treatments
  • The increasing value of insights especially around unmet patient needs, with the need to show improvements in patient-reported outcomes and real-world evidence (RWE)
  • The need to demonstrate value to different stakeholders, especially for high-priced medicines, with more focus on evidence to satisfy outcomes-based reimbursement models
  • The integration of companion diagnostics (including digital) into many therapeutic areas
  • The reduced reliance on sales representatives by healthcare professionals in favour of field medical support and digital information sources
  • The increasing demands for transparency around financial support provided to physicians
  • The need to ensure compliance with evolving national and supra-national regulations
  • The globalisation of information and alignment between regulatory authorities driving the need for global medical affairs functions

And coming back to our introductory theme, the digital transformation of healthcare will demand flawless virtual/hybrid engagement with stakeholders, using digital tools to both collect and disseminate knowledge and value.

Medical Affairs teams will play an increasingly strategic role in future, with earlier inputs into the product lifecycle so that clinical development programs are designed to address unmet patient needs and generate the data needed to demonstrate value to different stakeholders, while earlier stage research decisions best anticipate changes in the healthcare landscape.

Decision-making based on meeting the needs of patients and demonstrating value should translate into competitive advantage and improved return on investment for those companies that do this best.

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